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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ph, stomach
Regulation Description Stomach pH electrode.
Product CodeFFT
Regulation Number 876.1400
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to deploy 1015
Other (for use when an appropriate device code cannot be identified) 612
Failure to Adhere or Bond 161
Handpiece break 123
Unknown (for use when the device problem is not known) 68
Failure to advance 65
Difficult to deploy 43
No Known Device Problem 28
Device operates differently than expected 24
Connection issue 4
Device Issue 4
Premature deployment 4
Explanted 3
Loss of or failure to bond 3
Calibration error 3
Improper or incorrect procedure or method 3
Difficult to position 3
Failure to separate 3
Implant, removal of 3
No Information 2
Data Issue 2
Detachment of device or device component 2
Device, removal of (non-implant) 2
Trocar failure 2
Device, or device fragments remain in patient 2
Malfunction 2
Invalid sensing 2
Intermittent continuity 2
Break 2
Bent 2
Air leak 1
Detachment of device component 1
Foreign material 1
No display or display failure 1
Probe failure 1
Failure to transmit record 1
Device remains implanted 1
Component missing 1
Device contamination with blood or blood product 1
Suction issue 1
Material perforation 1
Difficult to remove 1
Replace 1
Reuse 1
Spring loading mechanism problem 1
Unexpected therapeutic results 1
Failure to power-up 1
Malposition of device 1
Calibration issue 1
Device or device fragments location unknown 1
Failure to disconnect 1
Positioning Issue 1
Total Device Problems 2216

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-06-2016
2 Medtronic Neuromodulation II May-07-2008

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